To Evaluate HU-014 in the Treatment of Post Stroke Upper Limb

Huons

Status and phase: Completed; Phase 3

Conditions: Post Stroke Upper Limb Spasticity

Treatments: Biological: HU-014 Inj

Study type: Interventional

Funder types: Industry

Identifiers

NCT05289921

HU-014_P3_ULS

Details and patient eligibility

About

Investigational Product: LIZTOX inj 100unit(HU-014) Title : Multi Center, Phase III Clinical Trial to Evaluate the efficacy and Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity Sites and investigators : Asan Medical Center(Seoul), Min-ho Chun, M.D, Ph.D Objective : To evaluate the efficacy and safety of LIZTOX inj in the treatment of Post Stroke Upper Limb Spasticity

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A subject who is diagnosed with Stroke at least six weeks prior to Screening.
• A subject who has Modified ashworth scale(MAS) score which Wrist Flexor is ≥ 2 and Flexor or Finger Flexor is ≥ 1.
• A subject with a Disability assessment scale(DAS)of at least ≥ 2 in one of the categories of hand hygiene, clothing, upper extremity, or pain for evaluation.

Exclusion criteria

• A subject who has medical history following. (Allergy, Chemodenervation(within 6 months), Tendon lengthening(within 6 months), Intrathecal baclofen.Aspiration pneumonia, etc.)
• A subject who has history of any diseases following. (neuromuscular junction disorder, NMJ, myasthemia gravis, MG, Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis, ALS, Skin disease, Dysphagia, etc.)
• From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks
• Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.
• A subject who tend to bleed or are taking anti-coagulant drugs.
• A sugject who is undergoing rehabilitation(physical therapy, occupational therapy, exercise therapy) or Splinting in the area where medication for clinical trials is scheduled to be administered.
• A sugject who has muscle atrophy, fixed joint/muscle contracture in the area where medication for clinical trials is scheduled to be administered.
• Any condition that, in the view of the investigator, would interfere with study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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198 participants in 2 patient groups

HU-014 Inj

Experimental group

Description:

HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)

Treatment:

Biological: HU-014 Inj

Clostridium botulinum type A

Active Comparator group

Description:

Clostridium botulinum type A Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)

Treatment:

Biological: HU-014 Inj